Varicose Vein Treatments - Medicare Advantage Form

Please refer to CMS website for the most current applicable National Coverage Determination (NCD)/ Local Coverage Determination (LCD)/Local Coverage Article (LCA)/CMS Online Manual System/Transmittals.
Type Title ID Number Jurisdiction Medicare Administrative Contractors (MACs) Applicable States/Territories Varicose Vein Treatments Page: 2 of 18 Chapter 16 General Exclusions from Coverage; Section 120 Cosmetic Surgery
Chapter 9 Radiology Services; Section H General Policy Statements Medicare Benefit Policy Manual Medicare NCCI Policy Manual Internet- Only Manuals (IOMs) National Correct Coding Initiative (NCCI) edits LCD
LCA Treatment of Varicose Veins of the Lower Extremities L34536 A56914 LCD
LCA Varicose Veins of the Lower Extremity, Treatment of L33575 A52870 LCD
LCA Varicose Veins of the Lower Extremity, Treatment of L34082 A57305 LCD
LCA LCD LCA LCD
LCA Treatment of Varicose Veins of the Lower Extremities Billing and Coding: Sclerosing of Varicose Veins Treatment of Varicose Veins of the Lower Extremities
Billing and Coding: Sclerosing of Varicose Veins Treatment of Chronic Venous Insufficiency of the Lower Extremities LCD LCA Treatment of Varicose Veins of the Lower Extremities LCD
LCA Treatment of Chronic Venous Insufficiency of the Lower Extremities L34209 A57706 A53084 L34010 A57707 A53079 L34924 A55229 L39121 A58876 L38720 A58250 J5, J8 - Wisconsin Physicians Service Insurance Corporation J6, JK - National Government Services, Inc. (Part A/B MAC) J15 - CGS Administrators, LLC (Part A/B MAC) JE - Noridian Healthcare Solutions, LLC JF - Noridian Healthcare Solutions, LLC IA, KS, MO, NE
IN, MI IL, MN, WI
CT, NY, ME, MA, NH, RI, VT KY, OH CA, HI, NV, American Samoa, Guam, Northern Mariana Islands AK, AZ, ID, MT, ND, OR, SD, UT, WA, WY JH, JL - Novitas Solutions, Inc. (Part A/B MAC) AR, CO, NM, OK, TX, LA, MS
DE, D.C., MD, NJ, PA
JJ, JM - Palmetto GBA (Part A/B MAC) AL, GA, TN
NC, SC, VA, WV JN - First Coast Service Options, Inc. (Part A/B MAC) FL, PR, U.S. VI

Varicose Vein Treatments Page: 3 of 18 Description Varicose veins are abnormally enlarged and tortuous vessels greater than three millimeters (3 mm) in diameter that usually result from reflux of blood caused by incompetent valves in the venous system. Rather than flowing forward, blood refluxes (flows backward) across the faulty valve and the resulting increased pressure causes the vein to dilate. The condition is further aggravated with the weakening of the affected vein's walls. Abnormal dilation may affect small reticular or feeder veins as well as superficial veins, located within or just below the skin. Reflux greater than or equal to 500 milliseconds (0.5 seconds) is generally considered clinically significant when combined with other symptoms. Perforator veins penetrate the deep fascia of muscles to form a connection between a deep venous system and a superficial one. They, or other larger veins that may communicate with the saphenous system, may become dilated and tortuous as their valves fail. This may occur anywhere on the leg between the groin and ankle and is commonly the result of reflux through the valve at the junction between the great saphenous vein (GSV) and the common femoral vein (saphenofemoral junction [SFJ]), or as a result of reflux through the valve at the junction between the small saphenous vein (SSV) and the popliteal vein (saphenopopliteal junction [SPJ]).
Recommendations for noninvasive management of varicose vein symptoms generally include daily exercise (walking), leg elevation (3 times daily for 30 minutes), leg exercises (ankle flexion) when seated and weight management. Prescriptions may be needed for venoactive medication and/or prescription compression hose.
Proposed treatments for varicose veins include, but may not be limited to: • Catheter-assisted venous sclerotherapy (KAVS catheter) uses an intravascular catheter with a balloon at the distal end to temporarily block blood flow to the segment of the vein being targeted for sclerotherapy. May also be referred to as endovenous catheter-directed chemical ablation with balloon isolation.
• Cryoablation (cryofreezing, cryostripping, cryosurgery, cryotherapy) involves the use of liquid nitrogen or argon gas at extreme cold temperatures to destroy venous tissue.
• Cyanoacrylate closure (CAC) (eg, VenaSeal closure system) delivers medical adhesive using ultrasound guidance via a catheter inserted into the target vein. The catheter is withdrawn, and pressure is applied to the vein.
• Endovenous thermal ablation techniques use heat energy to seal veins: o Endovenous laser ablation or therapy (EVLA or EVLT) utilizes a percutaneous catheter to deliver high- intensity laser light to induce photocoagulation of blood and occlusion of the vein. o Radiofrequency ablation (RFA), endovascular occlusion or endoluminal radiofrequency ablation (eg, ClosureFast [formerly known as Venefit or VNUS Closure system]) involves the delivery of controlled

Varicose Vein Treatments Page: 4 of 18 radiofrequency (RF) energy through a catheter inserted into the affected vein. The heat generated by the RF energy causes the vein to contract and become occluded. • Ligation and stripping consists of tying off and/or removing the varicose veins just under the skin, through several small incisions made along the veins. Once the veins are tied off and/or removed, the blood will flow through the deep veins back to the heart. Compression wrap to the leg(s) is used to limit bruising and swelling postoperatively. • Phlebectomy (ambulatory phlebectomy, microphlebectomy, miniphlebectomy, stab phlebectomy) is the surgical removal of veins through a small incision. • Sclerotherapy (endovenous chemical ablation) involves injecting a liquid or foam sclerosing agent into the targeted varicose vein, which causes irritation to the inner lining of the vein thereby causing it to collapse. After injecting the sclerosing agent, the extremity is tightly wrapped to keep the vein closed and enhance permanent closure. The body then absorbs the sclerotic tissue. Examples of types of sclerosants include chemical irritants, detergents, and osmotic agents. Sclerotherapy delivered by a specialized catheter with a rotating tip is called endomechanical or mechanochemical ablation (MOCA) (eg, ClariVein). The rotation action is thought to facilitate dispersing the infused medication into the bloodstream and to the targeted treatment area on the vessel wall. Sclerotherapy delivered using a drug/device combination product that dispenses a liquid sclerosant and low-nitrogen gas under pressure, from a proprietary canister is called polidocanol endovenous microfoam (PEM) (Varithena). • Subfascial endoscopic perforator vein surgery (SEPS) is a less invasive alternative to traditional open surgical treatment of chronic venous insufficiency. An endoscope is inserted into a small incision away from an ulcer site and balloon dissection is performed, with clips or scalpel interrupting incompetent perforator veins in the calf.
• Transilluminated powered phlebectomy (TIPP) involves endoscopic resection and ablation of superficial varicosities using an illuminator for vein identification and a powered resector that ablates the vein from underneath.
Coverage Determination Humana follows the CMS requirements that only allows coverage and payment for services that are reasonable and necessary for the diagnosis and treatment of illness or injury or to improve the functioning of a malformed body member except as specifically allowed by Medicare. In interpreting or supplementing the criteria above and in order to determine medical necessity consistently, Humana may consider the following criteria: When multiple procedures are requested, the criteria for each must be met.

Varicose Vein Treatments Page: 5 of 18 The use of ultrasound to guide catheter, device or needle placement during a procedure is considered integral to the primary procedure and not separately reimbursable.19, 26
Duplex ultrasound or Doppler imaging studies necessary for a procedure-related complication MAY be considered separately reimbursable.
General Requirements for Varicose Vein Treatments The general criteria for varicose vein treatments apply to all requests for treatment except sclerotherapy, phlebectomy for recurrent varicosities. Please see specific treatments for additional requirements.
Varicose vein treatment will be considered medically reasonable and necessary when the following general requirements are met:
• Duplex ultrasound or Doppler imaging study report shows clinically significant varicose veins AND documentation in the clinical records of at least one of the following: o Hemorrhage from venous varicosity; o Venous stasis dermatitis;
o Venous stasis ulceration;
o Symptoms of venous insufficiency of the lower extremities (ache, pain, muscle cramps, heaviness, edema, tightness) which interferes with activities of daily living,
AND
• Documentation in the clinical record of a discussion of personalized conservative therapy options, specific to the individual’s health needs, including but not limited to:
o Compression therapy with surgical grade stockings providing a minimum of 20 – 30 mm Hg pressure o Exercise plan with prescribed physical activity (eg, cycling, treadmill, walking) o Periodic leg elevation o Weight reduction Conservative therapy may be waived for individuals with any of the following: o Hemorrhage o Recurrent superficial thrombophlebitis o Skin changes attributable to venous disease, active or healed venous leg ulceration Procedures Without Additional Criteria The following will be considered medically reasonable and necessary when the above General Requirements for Varicose Vein Treatments are met. There are no additional criterion requirements for: • Cyanoacrylate closure (CAC), (eg, VenaSeal closure system) • EVLA, EVLT, RFA of Great or Small Saphenous Veins

Varicose Vein Treatments Page: 6 of 18 • Ligation and Stripping • Sclerotherapy, Phlebectomy – Initial/Adjunctive Criteria for Specific Treatments Unless noted otherwise, the following treatments must meet the above General Requirements for Varicose Vein Treatments for varicose vein treatments in addition to the individual criteria outlined below for each treatment.
Sclerotherapy, Phlebectomy for Recurrent Varicosities (General Criteria for Varicose Vein Treatments does NOT apply)
Sclerotherapy OR phlebectomy OR a combination thereof, to treat recurrent symptomatic varicose tributary, perforator or accessory veins will be considered medically reasonable and necessary when the following requirements are met: • Duplex scan report provides evidence of recurrent and clinically significant varicose veins AND at least one of the following: o Hemorrhage from venous varicosity; OR o Venous stasis ulceration; OR o Symptoms of venous insufficiency of the lower extremities (eg, ache, pain, edema, heaviness, muscle cramps, tightness)
Subfascial Endoscopic Perforator Vein Surgery (SEPS)
SEPS to treat symptomatic varicose perforator veins will be considered medically reasonable and necessary when all the following requirements are met: • Duplex ultrasound or Doppler imaging study report shows clinically significant reflux where the outward flow of duration is greater than or equal to 500 ms (0.5 seconds); AND
• Perforator vein diameter is greater than or equal to 3.5 mm; AND • The vein to be treated is located beneath a healed or open venous ulcer (Clinical, Etiology, Anatomy and Pathology [CEAP] classification of chronic venous disorders, class C5 - C6)27 Telangiectasias (General Criteria for Varicose Vein Treatments does NOT apply)

Varicose Vein Treatments Page: 7 of 18 The treatment of telangiectasias (spider veins, venules, reticular veins, superficial capillaries) will be considered medically reasonable and necessary ONLY in cases involving spontaneous hemorrhage.
The use of the criteria in this Medicare Advantage Medical Coverage Policy provides clinical benefits highly likely to outweigh any clinical harms. Services that do not meet the criteria above are not medically necessary and thus do not provide a clinical benefit. Medically unnecessary services carry risks of adverse outcomes and may interfere with the pursuit of other treatments which have demonstrated efficacy. Coverage Limitations US Government Publishing Office. Electronic code of federal regulations: part 411 – 42 CFR § 411.15 - Particular services excluded from coverage The treatment of telangiectasias (spider veins, venules, reticular veins, superficial capillaries) for any indication other than those listed above is considered cosmetic and is not considered medically reasonable and necessary.
Cosmetic surgery or expenses incurred in connection with such surgery is not a covered Medicare benefit. Cosmetic surgery includes any surgical procedure directed at improving appearance, except when required for the prompt (ie, as soon as medically feasible) repair of accidental injury or for the improvement of the functioning of a malformed body member. These treatments and services fall within the Medicare program’s statutory exclusion that prohibits payment for items and services that have not been demonstrated to be reasonable and necessary for the diagnosis and treatment of illness or injury (§1862(a)(1) of the Act). Note: This exclusion does not apply to surgery for therapeutic purposes which coincidentally also serves some cosmetic purpose.25
The following service will not be considered medically reasonable and necessary for the treatment of varicose veins: • Catheter-assisted venous sclerotherapy (KAVS catheter) (also referred to as endovenous catheter- directed chemical ablation with balloon isolation) A review of the current medical literature shows that there is no evidence to determine that these services are standard medical treatments. There is an absence of randomized, blinded clinical studies examining benefit and long-term clinical outcomes establishing the value of these services in clinical management.
The following services will not be considered medically reasonable and necessary for the treatment of varicose veins: • Cryoablation (also referred to as cryofreezing, cryostripping, cryosurgery, cryotherapy)

Varicose Vein Treatments Page: 8 of 18 • TIPP A review of the current medical literature shows that the evidence is insufficient to determine that these services are standard medical treatment. There remains an absence of randomized, blinded clinical studies examining benefit and long-term clinical outcomes establishing the value of this service in clinical management. Summary of Evidence Cryoablation (cryofreezing, cryostripping, cryosurgery, cryotherapy)
Studies have shown this treatment to be inferior to both conventional stripping and RFA. A randomized clinical trial with outcomes 5 years after treatment showed no significant difference between EVLA and cryostripping. A 2011 professional society guideline reported that the technique was new to the US, experience was limited, had not been fully evaluated and therefore no recommendation could be made.54 The same organization published a systematic review in 2023 and chose not to analyze cryostripping.27
Transilluminated Powered Phlebectomy (TIPP)
The TIPP procedure using the TRIVEX System (FDA-approved 2003), was intended as a less invasive alternative to standard varicose vein surgery. In the twenty years since inception, the published literature has failed to show a clear advantage to the procedure, other than requiring fewer and smaller incisions. While some studies showed results to be equivalent, others described patients experiencing more pain and/or bruising. Potential disadvantages to providers also include equipment requirements and a steep learning curve to mastery, despite the development of next-generation systems and techniques.54 TIPP has largely been replaced by more effective, less invasive techniques with high quality published evidence supporting their safety and efficacy.